Chase Tarnstrom Email & Phone Number

San Diego, California, United States

Washington, District Of Columbia, United States

• Individually responsible for developing sections of multiple NDA, BLA, and 510k submissions• Wrote technical documents and assisted in SOP development• Assisted in the development of regional regulatory strategy and updated strategy based upon regulatory changes• Investigated regulatory history/background of class and disease/therapeutic/diagnostic context in order to assess regulatory implications for approval• Possesses working knowledge of FDA 21 CFR, ISO, and GCP… Show more • Individually responsible for developing sections of multiple NDA, BLA, and 510k submissions• Wrote technical documents and assisted in SOP development• Assisted in the development of regional regulatory strategy and updated strategy based upon regulatory changes• Investigated regulatory history/background of class and disease/therapeutic/diagnostic context in order to assess regulatory implications for approval• Possesses working knowledge of FDA 21 CFR, ISO, and GCP standards• Experience with US and international regulatory policies, regulatory history, standards and practices, requirements and precedents, regulatory agency structure, and approval processes• Conducted regulatory research and developed technical documentation in support of a Class II 510k submission for a prescription digital therapeutic mobile medical app that delivered cognitive behavioral therapy• Developed detailed regulatory landscape assessments to determine if clients were required to conduct post approval studies for products currently on the market• Conducted policy research and analysis to present all potential regulatory options to clients including expedited regulatory pathways such as fast track, breakthrough therapy, accelerated approval, and PRIME: priority medicine• Managed submissions of complex scientific business proposals including coordination of multiple collaborators• Received first place in the company-wide Case Study Contest for a project entitled "The Assessment of Health IT and Real-World Evidence Policies Using Natural Language Processing and Knowledge Graphing Tools" Show less

Washington, District Of Columbia, United States

• Supported FDA division-level program management by creating status reports on 10 workstreams involving complex regulatory and scientific issues such as bioanalytical testing, pharmacological modeling, and genomics• Tracked the status of 60 research projects and 3 clinical trials within the Division of Applied Regulatory Science (DARS) to ensure deadlines are met• Supported laboratory information management system (LIMS) IT implementation across 5 DARS laboratories by presenting system… Show more • Supported FDA division-level program management by creating status reports on 10 workstreams involving complex regulatory and scientific issues such as bioanalytical testing, pharmacological modeling, and genomics• Tracked the status of 60 research projects and 3 clinical trials within the Division of Applied Regulatory Science (DARS) to ensure deadlines are met• Supported laboratory information management system (LIMS) IT implementation across 5 DARS laboratories by presenting system requirements to the Astrix Technology Group• Drove delivery of services for Booz Allen’s DARS project management support contract enabling it to expand from 2 to 8 billable personnel• Responsible for training 5 DARS project managers on best practices Show less

Bethesda, Maryland

• Reported to Booz Allen’s health team leadership on the current implementation status of projects related to digital health and patient-focused drug development• Provided project management support for 4 Center of Excellence in Regulatory Science and Innovation (CERSI) collaborations between DARS and universities such as Harvard, Johns Hopkins, and UCSF-Stanford• Led the steering committee for Center for Drug Evaluation and Research (CDER) Lab Day, an FDA-wide event with 500+ attendees… Show more • Reported to Booz Allen’s health team leadership on the current implementation status of projects related to digital health and patient-focused drug development• Provided project management support for 4 Center of Excellence in Regulatory Science and Innovation (CERSI) collaborations between DARS and universities such as Harvard, Johns Hopkins, and UCSF-Stanford• Led the steering committee for Center for Drug Evaluation and Research (CDER) Lab Day, an FDA-wide event with 500+ attendees including keynote speakers: FDA Commissioner Stephen Hahn and CDER Director Janet Woodcock• Received the Collective Ingenuity Gold Award for organizing the 2020 CDER Lab Day Show less

Rockville, Maryland

• Organized and coordinated 300+ internal meetings for the CEO and his leadership team and several conferences with high profile Fortune 500 clients• Received the Passionate Service Bronze Award for organizing the 2018 Civil Technology Strategy Summit